Can Alpha-Glucosidase Activity in Plasma or Leukocytes Serve as a Biomarker for Future Gene Therapy in Classic Infantile Pompe Disease? [0.03%]
血浆或白细胞中α-葡萄糖苷酶活性能否作为经典婴儿型庞贝病的基因治疗生物标志物？
Martha C Faraguna,Daniël A M Lambregts,Ina Barzel et al.
Martha C Faraguna et al.
We studied alpha-glucosidase activity in plasma and leukocytes after an infusion of 40 mg/kg of recombinant alglucosidase alpha in patients with classic infantile Pompe disease to assess the pharmacokinetics and identify potential surrogate...
Biosimilar Uptake in Spain from 2016 to 2023: Analysis Based on Official Data Collection [0.03%]
基于官方数据收集的2016至2023年西班牙生物类似药的使用情况分析
Jaime Espin,Zuzana Špacírová,Leticia García-Mochón
Jaime Espin
Even though the use of biosimilar medicines is increasing across European countries, detailed and regularly published official data on biosimilar uptake are not publicly available except in Italy and Portugal. The main objective of this stu...
Cell Engineering for Increasing Production of Recombinant Proteins in Mammalian Cells [0.03%]
哺乳动物细胞中增加重组蛋白生产的细胞工程
Xi Zhang,Yuan Shen,Zihan Guo et al.
Xi Zhang et al.
Mammalian cell lines are the preferred host cells for the biopharmaceutical industry. Chinese hamster ovary (CHO) and human embryonic kidney 293 (HEK293) cells are frequently utilized in the production of recombinant therapeutic proteins (R...
Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies [0.03%]
单克隆抗体皮下注射装置的临床验证
Beate Bittner,Javier Munoz,Sabine Frank et al.
Beate Bittner et al.
Subcutaneous autoinjectors serve as a convenient and user-friendly alternative to manual injection using prefilled syringes or handheld syringes, enhancing self-administration in decentralized care settings, patient compliance, and dosing a...
Xeligekimab, an Interleukin-17A Antagonist for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 48-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study [0.03%]
一项针对中国活动性放射学轴向脊柱关节炎患者的III期、随机、双盲、安慰剂对照研究：Xeljanz（托法替布）作为IL-17A拮抗剂的疗效和安全性——第16周和48周结果
Shangzhu Zhang,Dong Xu,Shengyun Liu et al.
Shangzhu Zhang et al.
Background: Xeligekimab is a novel immunoglobulin G4 (IgG4) monoclonal antibody targeting interleukin-17A (IL-17A). In a phase III trial in patients with plaque psoriasis, xeligekimab showed efficacy and safety consistent...
Pharmacokinetic Similarity of Biosimiliar AVT05 Versus Reference Product Golimumab in Healthy Adults: A Double-Blind, Three-Arm, Parallel-Group Study [0.03%]
一项有关Avtrix公司研发的AVT05与原研药戈利木单抗在健康成人受试者中具有相似药代动力学的双盲、三臂组平行对照Ⅰ期临床研究
Chris Wynne,Ulrike Lorch,Edrich Krantz et al.
Chris Wynne et al.
Background: AVT05, a recombinant, human, immunoglobulin G1қ monoclonal antibody, is a biosimilar to Simponi®. Objectives: The purpose...
Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study [0.03%]
AVTO05与戈利木单抗类似物与甲氨蝶呤联用治疗中重度类风湿性关节炎的有效性和安全性：一项随机、平行分组、双盲研究的52周结果
Monica Luque,Kristina Zhelyazkova,Laxmikant Vashishta et al.
Monica Luque et al.
Background: Golimumab is a safe and effective treatment for patients with rheumatoid arthritis. Biosimilars to the reference product (RP; Simponi®) may make treatment more accessible. ...
Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study [0.03%]
关于生物类似药监管趋同和精简发展的国际定性研究报告建议
Elif Car,Liese Barbier,Ingrid Schwarzenberger et al.
Elif Car et al.
Objectives: This study aims to assess perspectives of stakeholders on scientific and regulatory challenges associated with biosimilarity demonstration and to formulate consensus-based recommendations to foster regulatory ...
Biological Therapies in Chronic Obstructive Pulmonary Disease: New Directions in Personalised Respiratory Medicine [0.03%]
慢性阻塞性肺疾病的生物疗法：个性化呼吸系统医学的新方向
Benjamin Mappin-Kasirer,Ian D Pavord
Benjamin Mappin-Kasirer
Chronic obstructive pulmonary disease (COPD), a leading cause of global morbidity and mortality, is a complex and heterogeneous respiratory condition characterised by incompletely reversible airflow obstruction on spirometry. The aetiologie...
Bidirectional Interplay Between IBD Therapies and the Gut Microbiota: A Pharmacomicrobiomic Approach to Personalized Treatment [0.03%]
IBD治疗与肠道微生物组的双向相互作用：个性化治疗的药物微生态学方法
Slavica Lazarević,Maja Đanić,Nebojša Pavlović
Slavica Lazarević
The interplay between inflammatory bowel disease pharmacotherapies and the gut microbiota is increasingly recognized as a pivotal factor influencing treatment efficacy and patient outcomes. This review provides a comprehensive and up-to-dat...